transfusion: Restrictive Versus Liberal Transfusion, Major Surgeries

Sponsor
Leyla Kılınc (Other)
Overall Status
Completed
CT.gov ID
NCT03394274
Collaborator
(none)
892
1
5.1
176.3

Study Details

Study Description

Brief Summary

Investigators aimed to compare the restrictive and liberal blood transfusion methods applied in major surgical operations performed in Anesthesiology and Reanimation Clinic and investigate their effects on postoperative transfusion needs, morbidity and mortality.

Condition or Disease Intervention/Treatment Phase
  • Other: restrictive and liberal transfusion

Detailed Description

The test subjects consisted of 892 patients, who belong to ASA (American society of Anesthesiology) I -IV groups, underwent elective major surgery between the 01/01/2016-31/12/2016, and are over the age of 18 years. The demographic data (Age, sex, ASA (American society of Anesthesiology) scors, surgery type) were also recorded. we evaluated the value of Hemoglobin, platelet, APTT (activated partial thromboplastin time), INR (international normalized ratio) preoperatively and postoperatively. In this study, restrictive and liberal blood transfusion groups were investigated.restrictive and liberal transfusion hemoglobin threshold value respectively before perioperative transfusion was 8 g / dL. were defined as restrictive blood transfusion group and perioperative transfusion was over 8 g / dL were defined as liberal blood transfusion group. Adverse events (tachycardia, hypotension, the value of lactate and metabolic acidosis). Postoperatively, the amount of postoperative transfusion unit, duration of hospital stay, requirement of intensive care unit and mortality rate.

Study Design

Study Type:
Observational
Actual Enrollment :
892 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Restrictive Versus Liberal Transfusion for Elective Major Surgery and Perioperative Outcomes: Mortality, Morbidity and Requirement of Postoperative Blood Transfusion
Actual Study Start Date :
Jun 14, 2017
Actual Primary Completion Date :
Sep 15, 2017
Actual Study Completion Date :
Nov 15, 2017

Arms and Interventions

Arm Intervention/Treatment
Transfusion

Patients (n:892) were enrolled who underwent elective major surgery between the 01/01/2016-31/12/2016, and over the age of 18 years. They separated subgroups as restrictive and liberal blood transfusion groups

Other: restrictive and liberal transfusion
hemoglobin threshold value was accepted 8g/dl. restrictive blood transfusion group was defined that if perioperative transfusion was started equal or under hemoglobin level 8 g / dL. Liberal blood transfusion group was defined as perioperative transfusion was started over hemoglobin level 8 g / dL .

Outcome Measures

Primary Outcome Measures

  1. Restrictive or Liberal transfusion [52 weeks]

    It is determined how many units of RBC (red blood cell ) used during major operations at the hospital in liberal transfusion group or restrictive transfusion group.

Secondary Outcome Measures

  1. Mortality [52 weeks]

    Survival ratios between the restrictive transfusion group and the liberal transfusion group are compared.

  2. Postoperative transfusion requirement [52 Weeks]

    The requirement of postoperative blood transfusion between the restrictive transfusion group and the liberal transfusion group is determined.

  3. The Need of ICU [52 Weeks]

    The need of ICU between the restrictive transfusion group and the liberal transfusion group of patients is determined.

  4. Postoperative Duration of Stay in Hospital of patients [52 Weeks]

    The postoperative duration of stay in hospital of patients between the restrictive transfusion group and the liberal transfusion group are compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Over 18 years old patients,

  • ASA I-II-III-IV,

  • Major surgeries ( Intra-abdominal, intracranial, head and neck malignancy surgery, femur and vertebra surgery)

Exclusion Criteria:
  • Emergency operation,

  • Cardiovascular surgery,

  • ASA V-VI

  • Under 18 years old patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Health sciences,sisli Hamidiye Etfal Training and Research Hospital Istanbul Turkey 34371

Sponsors and Collaborators

  • Leyla Kılınc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Leyla Kılınc, medical doctor, anesthesiology specialist, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT03394274
Other Study ID Numbers:
  • 814
First Posted:
Jan 9, 2018
Last Update Posted:
Jan 11, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leyla Kılınc, medical doctor, anesthesiology specialist, Sisli Hamidiye Etfal Training and Research Hospital

Study Results

No Results Posted as of Jan 11, 2018